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In Brief: FDA Seeks Cosmetics Comments; L’Oreal/Magic Deal Approved; More

FDA will reopen comments for cosmetics regarding its final guidance on Investigational New Drug Applications. China’s Ministry of Commerce approves L’Oreal’s acquisition of Magic Holdings. More.

In a Jan. 16 update from FDA’s Center for Food Safety and Applied Nutrition, the agency says it plans to reopen a comment period specifically on the cosmetics and food portion of its final guidance “Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an IND” issued in September. The guidance suggests that certain cosmetic studies involving human subjects could require an Investigational New Drug Application, “even if the study is intended to support a cosmetic claim about the ingredient or product’s ability to cleanse, beautify, promote attractiveness or alter the appearance, rather than a structure/function claim” which could characterize the ingredient or product as a drug. The agency says it will publish a Federal Register notice at a later date to announce the reopening of the comment period.

L'Oreal SA has received approval from China’s Ministry of Commerce to acquire Magic Holdings International Limited of China, according to a Jan. 13 announcement, which notes that other preconditions...

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